The following data is part of a premarket notification filed by Biomedical Composites, Ltd. with the FDA for Fibreflex.
Device ID | K871312 |
510k Number | K871312 |
Device Name: | FIBREFLEX |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | BIOMEDICAL COMPOSITES, LTD. N89 W16785 APPLETON AVE. Menomonee Falls, WI 53051 |
Contact | Richard Mullarky,dds |
Correspondent | Richard Mullarky,dds BIOMEDICAL COMPOSITES, LTD. N89 W16785 APPLETON AVE. Menomonee Falls, WI 53051 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-01 |
Decision Date | 1987-04-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FIBREFLEX 77365647 not registered Dead/Abandoned |
Pentair Filtration, Inc. 2008-01-07 |
FIBREFLEX 76483875 2950892 Live/Registered |
G & S Surfboards, Inc. 2003-01-13 |
FIBREFLEX 73733978 1524362 Dead/Cancelled |
BIOMEDICAL COMPOSITES LTD. 1988-06-13 |